Feasibility and Acceptability of Empowered Relief for American Indians With Pain During and After Cancer Treatment

Обзор

This project will evaluate the feasibility and acceptability of Empowered Relief (ER) among American Indian adults who are currently receiving or have completed active cancer treatments at Stephenson Cancer Center (SCC). ER is a single-session, Zoom-based, 2-hour, skills-based pain management class delivered by certified instructors. Participants learn three core pain relief skills, develop a personalized plan, and receive access to a free binaural audio app for daily practice. ER has demonstrated moderate efficacy in individuals with chronic non-cancer pain, reducing pain intensity, pain interference, pain-related distress (pain catastrophizing), sleep disturbance, and anxiety at 3 and 6 months post-treatment. Because of its brief, didactic nature and Zoom delivery, ER can accommodate large class sizes and may address accessibility disparities among underserved cancer populations. While ER is being studied across various non-cancer populations and has been adopted as standard of care in leading healthcare institutions in the U.S. and abroad, it has not been tested in American Indians with cancer.

Вмешательства

• Поведенческое Empowered Relief
  ER is a single-session, Zoom-based, 2-hour, skills-based pain management class delivered by certified instructors. Participants learn three core pain relief skills, develop a personalized plan, and receive access to a free binaural audio app for daily practice. ER has demonstrated moderate efficacy in individuals with chronic non-cancer pain, reducing pain intensity, pain interference, pain-related distress (pain catastrophizing), sleep disturbance, and anxiety at 3 and 6 months post-treatment.

Первичные конечные точки

• Feasibility of ER in American Indian populations [Срок оценки: From participant accrual to the completion of their 3-mon follow up survey (approx. 4 months)]
• Identify areas for cultural tailoring and improvement of ER [Срок оценки: Assessed as part of the optional (n=30) Qualitative Post-class interview. (approx. 30 minutes)]
• Pain Intensity [Срок оценки: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class]
• Pain Interference [Срок оценки: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.]
• Emotional Distress [Срок оценки: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.]
• Sleep Disturbance [Срок оценки: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.]
• Perceived Quality of Life [Срок оценки: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.]

Критерии участия

Критерии включения

• Identifies as American Indian
• Has history of a cancer diagnosis
• Is currently undergoing or has completed active cancer treatment
• Experiences body pain most or every day
• Pain duration at least 3 months
• English fluency

Критерии исключения

• Significant psychological and cognitive impairment that limits one's ability to complete study tasks (completion of online survey, attending the Zoom-based ER class)
• Life-threatening acute illness (e.g., infection, heart attack, injury)
• No access to a computer, a smartphone, or a tablet

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Stephenson Cancer Center - Tulsa Location — Tulsa

Идентификаторы

NCT: NCT07742449 · 20065Ph1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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